MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION; FILTER, INFUSION LINE

Model Number	2N3350
Medical Device Problem Codes	Device-Device Incompatibility (2919); No Flow (2991); Protective Measures Problem (3015)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that unspecified units of non dehp micro volume extension sets caused downstream occlusion alarms on the baxter pump.The tubing was inspected for unclamped clamps and kinks; no issues were identified.The pump was restarted; however, still observed downstream occlusion alarms.It was subsequently determined that the 0.2 micron filter was not compatible with the pump.A new bag of paclitaxel was prepared with a different 0.2 micron filter, after which the pump functioned without occlusion alarms.The previous day, similar occlusion alarms occurred during paclitaxel administration when the same filter was connected to the short set.The filter was removed and repositioned on the flush line closer to the patient and the infusion continued without issues.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
Additional Manufacturer Narrative
B3: the events occurred on 05/03/2026 and 05/04/2026.D4: unique device identifier (udi) # is based on the di information as no lot number was provided by the reporter.H11: the devices were not returned and the lot number is unknown; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: NA
• Common Device Name: FILTER, INFUSION LINE
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE - HAINA; parque industrial itabo; carretera sanchez km 18 1/2; haina 21426 ; DR 21426
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242705355
• MDR Report Key: 25410845
• Report Number: 1416980-2026-01918
• Device Sequence Number: 12216228
• Product Code: FPB
• UDI-Device Identifier: 00085412004846
• UDI-Public: (01)00085412004846
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K113227
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/05/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 2N3350
• Device Catalogue Number: 2N3350
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/07/2026
• Initial Report FDA Received Date: 06/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BAXTER PUMP; PACLITAXEL; UNSPECIFIED SET
• Patient Sex: Unknown